CN
IRE High Voltage Steep Pulse Therapeutic System
Product makes use of targeting of irreversible electroporation to encircle and perish tumor cells.
Product has obtained NMPA license and CE certification.








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The system makes use of  targeting of  irreversible electroporation to encircle and perish tumor cells,it has obtained NMPA license and CE certification.

Through electrodes placed in target tissues, High Voltage Steep Pulse Therapeutic Apparatus releases high voltage direct current pulses. The electric pulses generate electric filed and form high current occurred at lipid bilayer of cell membrane and create nano-sized irreversible structural pores . After sufficient high voltage steep pulses are supplied,apoptosis occur, continuous and effective ablation areas are produced around and within the electrodes. The most outstanding advantage of the technology lies in its protection of vital vessels such as blood vessels, bile ducts,pancreatic ducts and nerves within the target area whilst completely ablating target tumor cells.



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In 2017,Steep Pulse Therapeutic Apparatus obtained national certificate of patent for utility model.(Figure 1)

In 2018,Steep Pulse Therapeutic Apparatus obtained national certificate of patent for an invention and  national certificate of patent for utility model.(Figure 2、Figure 3 )

In 2019,Steep Pulse Therapeutic Apparatus was certified by ISO13485 system of the European Union.

In 2019, Steep Pulse Therapeutic Apparatus completed clinical trial  successfully and obtained CE certification.(Figure 5)

In July 2021,Steep Pulse Therapeutic Apparatus obtained the first registration certificate for medical device(Class III) which is targeted at hepatic malignant solid tumors in irreversible electroporation field.(Figure 6)


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